Arcondis

Validation Office

Validation projects are imminent or are currently being implemented. The project management and the team are in place. However, there are bottlenecks in resource management. Scheduling problems in the implementation of the CSV (Computer System Validation) project have arisen. This is where Arcondis with its extensive CSV expertise can help. We support your CSV project or your software changes and ensure a successful completion. We also help you to create experience reports, revise specification documents, carry out risk assessments of functionality, identify whether the scope of the tests is adequate and draw up validation plans and reports. One prerequisite is a documented CSV procedure for the company, for example, in the form of a validation master plan (VMP). We will be happy to help you produce a VMP if you do not already have one.

Starting point

  • Need for support during an on-going validation project

  • The progress of the CSV project is unclear

  • Guaranteeing the inspection security of a CSV project

  • Need for in-depth CSV expertise to provide support for a CSV project

  • Implementing quality control in CSV projects or during the maintenance of validated systems

Our contribution

  • Reviewing validation documents (project audit)

  • Taking responsibility for individual CSV tasks to support the implementation of the CSV project

  • Quality control, risk assessment and impact analysis of CAPAs and defined changes to GxP-related applications

  • Creating VMP/CSV guidelines using business processes and IT SOP specifications

  • Quality control in validation projects

Your benefit

  • Successful conclusion of your CSV project

  • Structured, pragmatic CSV procedure

  • Precise project analysis including necessary correction recommendation

  • Inspection security for CSV projects

  • Resolving resource bottlenecks in individual validation tasks

  • Closing gaps in CSV projects in preparation for audits

NewsFlash April 2012

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